cough syrup deaths – A month after deaths of children from contaminated cough syrup were reported in Madhya Pradesh and Rajasthan, the Telangana Drugs Control Administration (DCA) has issued a new directive stating that each batch of essential solvents like glycerin, propylene glycol, sorbitol solution used in the manufacturing of liquid oral medicines should be purchased exclusively from suppliers registered on the National Digital Surveillance System. The instructions are part of a detailed follow-up circular issued to all liquid oral manufacturers.
This circular is based on an earlier communication issued on October 13, which had made testing of diethylene glycol and ethylene glycol mandatory at every stage of manufacturing. A key direction in the latest advice concerns the mandatory digital trail for the above-mentioned high-risk solvents. The DCA has said that manufacturers of these solvents should be registered under the digital monitoring system on the online National Drugs Licensing System (ONDLS) portal of the Central Drugs Standard Control Organization (CDSCO).
The circular states that liquid oral manufacturers can use batches of such solvents only if they originate from entities listed on this digital system, making it mandatory for companies to verify the registration status of each consignment. The circular also reiterates the responsibility of manufacturers to comply with supplier audit and approval rules.
This includes verifying the reliability of suppliers who provide ingredients such as glycerin, propylene glycol, and sorbitol solutions. When necessary, audits should assess whether suppliers can meet Good Manufacturing Practice standards, while evaluations should consider past performance and the nature of the materials supplied. DCA has cautioned that any negligence in following these instructions including the previous circular will be viewed extremely seriously.
Regulatory and punitive action will be initiated against manufacturing firms and responsible personnel in cases of non-compliance. The circular makes it clear that strict adherence to these instructions is mandatory.